Why You Should Attend 10x Sessions

10x is the thought leaders forum for medical device professionals at all levels who design, develop, manufacture, or commercialize devices.
It's where you'll have interesting conversations with speakers that get your creative juices flowing. Learn from experts about everything from concept to commercialization and be part of a movement of medtech people who give as well as take.
Importantly, 10x staff think of you as guests in our home. We'll personally introduce you to people you want to meet. And we serve ice cream(!) because we believe touches like these mean a lot and bring happy alumni back show after show.

Now, to bring you more value, we're nesting 10x inside MDTX, the Medical Device Technology Exchange, so you can walk the exhibition hall of medical device suppliers when class is not in session. There, you'll discover new technologies, resources, and materials you didn't know existed and meet the companies who can help you grow your business.
We look forward to educating and inspiring you.

The Medical Devices Group

(345,000+ members)

The Medical Devices Group is the world’s largest medical device community and the industry’s only spam-free, curated forum for intelligent conversations with medical device thought leaders.

Who Attends 10x

Our guests tend to be medical device company CEOs, presidents, vice presidents, directors, and senior managers, as well as business development executives from medical device consultancies. Read more >>

We offer discounts for groups of 3, the unemployed, and for students. Click here if you qualify for these limited and discounted seats.

The revised ISO 13485 standard expects you to apply a “risk based approach” to all of your organization’s QMS processes, specifically stating you’ll need to apply risk management methods and techniques to every single QMS process, including outsourced processes as well.

This presentation will give product developers and manufactures a thorough insight into the specific risk-based changes they’ll need to understand to comply with the revised standard.

• How to apply a “risk based approach” to all your organizations QMS processes
• An overview of the current risk management standard for medical devices: ISO 14971
• Relevance of ISO 14971 and ISO 13485:2016
• How to incorporate risk management throughout the design control process and why it matters
• An overview of key risk management terms & definitions
• How to use risk management as a tool during design & development, and not simply as a “checkbox” activity

“The FDA gives you permission to sell your technology, but it doesn’t give us a single reason why we should buy it.”– An official from the Centers for Medicare and Medicaid Services (CMS)

Innumerable medical devices and diagnostics make it all the way through proof-of-concept, venture capital funding, patenting, and FDA clearance only to be denied coverage and reimbursement by CMS and private payers. A myth still abounds that FDA clearance is the ultimate hurdle. Those believing this myth, however, sail over the FDA hurdle only to smash into the wall that is the payer system. Where’s the disconnect?

Health economics is an area of research that manufacturers often want to ignore when developing a new product – and it’s killing them.

What’s more, reimbursement rules are continually changing, and your established value proposition has to be continually updated and re-proven to adapt to the changing market environment. This, even if your product has a history of successful market access and utilization.

Beth has 15+ years of experience as a health economist serving the device and diagnostic industry and understands the combined clinical and economic value arguments medtech companies need to make to payers.

In this workshop, Beth will share secrets for obtaining reimbursement – or getting paid – by any one of a number of customers. The morning will be filled with case studies providing concrete examples of what to do – and what not to do – to achieve and maintain market success. Best of all, Beth works extensively with small medtech companies and know how to achieve more with less. This is a session you shouldn’t miss.

“We don’t innovate enough.”
“Our idea of innovation is adding a button or changing the color.”
“Even if we did innovate, our biggest competitor would copy us almost immediately.”

Serial entrepreneur and medical device inventor Jeffrey Carlisle has heard it all. He’s watched companies kill innovation very effectively. Yes, every device can “add a button” or “come in a different color,” but these aren’t true innovations and everyone – sales, employees, and customers – know it.

Jeffrey has identified where companies go awry and has a prescription to re-energize your innovative efforts. He’ll cover “15 Time-Tested Innovation Killers” so you know them when you see them, and give you strategies to inoculate you and your organization from them.

You’ll leave with seven actionable steps you can take to foster a thriving culture of innovation. And you’ll receive a copy of Jeffrey’s book, “We Love Innovation, so long as it’s nothing new.”

Everyone wants to get their device to market as quickly as possible, but the biggest delay is not 510(k) clearance. If you complete the required testing before you submit your 510(k), your 510(k) should take 90-120 days to receive clearance.

Typically the testing required for submission will take equally long – if not longer. If you miss a required test, then your 510(k) clearance is likely to be delayed another 180 days while you perform the testing you missed and submit the additional testing reports.

The most important thing you can do to prevent delays in your product launch, is to make sure you apply risk management and design controls as early as possible, during the planning of your project.

In this workshop, you will learn a step-by-step approach for identifying the regulatory pathway, testing requirements and verifying these requirements before you even begin your testing. This is all part of an integrated approach to planning of design and risk management for medical devices.

Attendees will also receive an electronic template for an integrated design and risk management plan.

The introduction of the MEDDEV 2.7/1 Rev. 4, in June 2016, is part of the significant changes happening across the medical device regulatory landscape.

This particular change is connected to introduction of the EU MDR enacted in 2017 and will significantly impact the procedures surrounding post-market clinical information, device equivalence, and clinical evidence at medical device companies. Although writing of Clinical Evaluation Reports was already a requirement for EU compliance, the previous revision of this MEDDEV didn’t provide much structure – neither to the manufacturer or to the Notified Body. As such, Clinical Evaluation Reports were relatively easily accepted. This has been changed.

The MEDDEV update made the Notified Bodies change their process, focusing on detail and now expecting a considerable effort from the manufacturer. What does this mean for manufacturers? They must gather more data, provide more analysis, and update their existing reports for all the devices in their portfolio, in an almost unworkable short amount of time…

In this workshop, Christine Zomorodian and Anne Leijsen will guide you through the development of process and the creation of the new clinical evaluations.

Christine is the ideal person to guide the process of designing a clinical evaluation structure in the context of your company. With the increased focus on post-market medical device data, Clinical Evaluations have become a focus of notified body review efforts. When should your clinical evaluations be performed? What information needs to be collected? And how do you ensure that there is a continuous process that allows evaluation of all your currently-marketed devices?

At the same time, Anne would be the best person to provide you all information you need for the creation of clinical evaluations. She has been working on numerous Clinical Evaluation Reports, submitted to and been accepted by several Notified Bodies. She will guide you through the exact requirements of the data gathering and writing processes: What are the steps that are to be taken? Where should you put the focus of the evaluation? What data shall be captured, and what shall be done if there is not much data available on your device? Who should be involved in the clinical evaluation process to get the best results? And what are the differences between clinical evaluations for different device classes?

If your work remotely touches this area, you should be in this workshop.

For medical device companies, ineffective communication with FDA often leads to time-consuming and costly delays. Manufacturers may assume a classification or regulatory pathway for a new device – only to learn later that FDA disagrees. Unfortunately, most of these delays are completely avoidable!

The ‘pre-sub’ program – an expansion of the pre-IDE program– allows manufacturers to request meetings regarding devices currently under development and/or regulatory review. Although CDRH issued guidance on the pre-sub program in 2014, many companies do not use this program effectively, and some don’t use it at all for fear their regulatory burden will be increased rather than reduced.

When used effectively, pre-subs can offer significant advantages to the manufacturer by getting their device to market sooner. But if not used properly, pre-subs can add tremendous burden by increasing time to market. This presentation will use the case study approach to present the pre-sub process in an interactive fashion including:
• When should the pre-sub program be used and when should it not be?
• How does the process work and what can the manufacturer expect?
• When is it better to meet formally or informally? Should you meet in person or via teleconference?
• What info should be provided in advance and what should be provided at the meeting?
• What happens after the meeting? How should the manufacturer follow-up? Are the results binding?
• Are there other ways to communicate with FDA beyond pre-subs and when should they be used?

In this presentation, participants will learn best practices to avoid timely and costly mistakes and creative ways to use the pre-sub program to their advantage! For additional information, check out:
• Column: How To Make The Most Of Your Pre-Sub Interactions with FDA (Med Dev Online, Feb, 2015) here.
• Column: Communicating With FDA: How (And When) To Get It Right (Med Dev Online, June, 2015) here.
• Editorial: 3 Tips To Vastly Improve Your FDA Communication Strategy (MDDI, May, 2014) here.
• Podcast: How To Make The Most Of Your Pre-Submission Interactions With FDA here.
• Podcast: How to Properly Use the FDA Pre-Submission Process and Why It’s So Important here.
• Podcast: When And How To Interact With The FDA (MED Device Online, March, 2015) here.
• Workshop: FDA Pre-Submission Meetings: Strategies for MedTech Entrepreneurs (MassMEDIC, March, 2017) description here / podcast and handout here.
• Webinar: Communication With FDA: What Do We Say and How Do We Say It? (GWU, Jan, 2016) here.
• Guerrilla Regulatory Strategy (MED Dev Online), GreenLight.guru podcast series and Mike on Medtech (MPO Magazine)

Uncovering User Needs for any Medical Product is now an important aspect for the FDA. However, for a typical startup, this means balancing the technology with usability. There is an increased demand for new devices ranging from combination products to medical devices. Products are crossing boundaries from pharmaceutical and biologic delivery systems forcing a need for increased collaboration in the design of complex systems in the medical and life science device development.

In certain cases, there is a need to capture a wide variety of technical and user information that is used by various disciplines including engineering and marketing. Opportunities exist to capture early user needs that can challenge the existing technological platform, leading to a product pivot.

This 2-hour workshop will focus on teaching user centered design, design thinking, and research methodologies to help develop real world requirements. Additionally, it will focus on the collaboration needed with systems engineering to concurrently develop and test minimally viable products prior to translating the user needs and technical requirements in formal documentation to Design and Engineering disciplines and creating a value proposition by defining user needs.

Participants will receive valuable material regarding Exit Strategy including:
• When do I start thinking about an exit strategy?
• What are the best ways to maximize value in my business?
• What are the exit options available to me at different stages: early, commercialization, mature
• What is the current state of obtaining private equity versus strategic buyers

• Getting cost-effective access to new product ideas from individual physicians and university tech transfer offices
• Determining the main issues/difficulties in working with physicians
• Illustrating what physicians really want and need when working with engineers

Collaborating with your customers AND internal stakeholders (e.g., sales, marketing) is absolutely essential to creating delightful user experiences for your products and services. Within the field of User Experience Design, there are a myriad tools and techniques available to us to allow for participatory feedback throughout the design process.

This session will provide attendees with UX improvement strategies and techniques that you and your organization can begin to implement immediately. We’ll cover:

How to use input from Sales and market Research to inform product design and research

The medical market has evolved over the past several years and is facing unprecedented challenges. Increased government regulation, heavy cost pressures from local competition in emerging markets, and increased public pressure to achieve sustainability are challenging companies to drive operational efficiency and revisit material selection in order to succeed in the global medical market.

This presentation focuses on the shift from plasticized substrates to new materials such as TPEs, the drivers behind the change, the implications this change has on the market, and material and bonding selection including the use of light cure adhesives that optimizes total cost of ownership that is both regulatory-compliant and sustainable.

Patients are driving the miniaturization on ambulatory devices with increased emphasis on more functionality, more comfort, portability and self-powered devices. This growing trend towards making devices smaller allows for less invasive procedural techniques and helps reduce the length of hospital stays which reduces costs.

With the development of smaller components and drive systems, we can easily develop custom solutions that deliver on OEM’s next big ideas. During this session, we’ll discuss the driving factors on miniaturization, technologies that enable the micro approach, design aspects that make it possible, best practice impact on assembly, robustness and cost factors.

With his in-depth knowledge of drive systems, Mr. Horn will use real application examples, to show how miniaturization have made things possible today that were not years ago. In addition, we will look at the following:
• Technologies on winding, magnets and PCB’s.
• The impact on implants and solutions based on titanium and ceramics.
• Design aspects and how to get started using the inside-to-outside design approach, replace tolerances by elasticity, divide functions, and reduce interfaces and integration.
• The impact on the risk status.

A case study will be presented that visually demonstrates how upstream contextual inquiry maps user experience to robust device requirements and design inputs resulting in a dynamic trace matrix. This case study demonstrates how to effectively apply a usability design process, employing human factors engineering methodologies (including task analysis and use risk assessment) integrated with industrial design techniques (such as User Experience (UX) mapping and participatory design). The case study then demonstrates how the trace matrix connects concept design features with user requirements, traceable all the way back to the original UX map.

Main Objectives and Takeaways:
• How Contextual Inquiry can map UX insights that drive requirements and design inputs
• Developing rationales for User Requirements in a dynamic trace matrix
• Reducing risk during concept development through pragmatic usability design techniques

In his talk, Ames Gross will share case studies and discuss:
• When sourcing and manufacturing in Asia may be worth your consideration
• Best strategies to source in India’s medtech market
• How to set up a greenfield medtech manufacturing facility in China and India
• The most effective way to ensure quality assurance from factories abroad

This is a case study which couples together technical theory of operation with applied human factors. While usability testing is a strong topic of conversation due to FDA human factors guidance, the application of HF principles is implemented in the initial product design.

This presentation will delve into the process of assessing anthropometry and biomechanics towards effective user interfaces. This includes discussion on the criteria for Ease of Use and why Ease of Use by itself is a poor design requirement. Overall themes and concepts will be presented using a case study model.

LEARNING OBJECTIVES:
• Takeaway #1: How to apply human factors to technical design through the development of concept theory of operation.
• Takeaway #2: Key principles that when combined contribute to overall ease of use.
• Takeaway #3: How to use AAMI HE 75 for preliminary heuristic analysis for design
• Takeaway #4: Why this process can expedite success in formative/summative usability studies

Since Bitcoin was first released in 2009, it and other cryptocurrencies have surged in popularity, eclipsing a combined value of $300B in November, 2017. Bitcoin’s major innovation was the utilization of a cryptographic, immutable, distributed ledger, known as a “blockchain,” that is used to keep track of all bitcoin transactions. It turns out the underlying blockchain technology can be leveraged in far more than just monetary systems, and can be abstracted to hold arbitrary types of data. From healthcare, to real estate, to education, to finance, many of these industries depend upon trusted intermediaries to share and distribute information; where there are trusted intermediaries, there is an opportunity for blockchain to disrupt.

In this presentation Jad will briefly cover the basics of blockchain, with a focus on potential applications within the medical space. He will also present the work he’s done during his master’s dissertation demonstrating the feasability, and utility, of a blockchain-based care coordination system.

Attendees will leave with a better understanding of the types of problems blockchain can solve, and some potential applications of blockchain within the medical space that include, but are not limited to, supply chain logistics, IoT devices, health record management, health data markets, and more.

Walt Maclay will discuss the issues involved with bringing wearable medical devices from an idea to FDA approval based on his firms many experiences. He will discuss areas including user interface issues, battery life, different sensing technologies, data security, and verification to meet FDA and CE requirements.

We are seeing explosive growth in wearable health monitors for healthcare and fitness applications. Many of these devices stick to the skin. This talk will explore the challenges of the skin as a substrate, and considerations for selection of the proper adhesive. In addition, Dr. Eitzman will discuss the challenges of “long wear” device attachment and share results of some recent in-house clinical studies completed at 3M.

When designing and developing a medical device, companies often consider labeling down the road, but they shouldn’t. Labeling can involve a variety of ways a medtech company markets a product. What presenter Michael Drues calls high-level labeling – indications for use, intended use and label claims – drives to the heart of a company’s regulatory strategy.

Depending on the high-level labeling, the same product could be a wellness device not regulated as a medical device – or a device requiring a 510(k), de novo or PMA. Companies also need to balance out how the labeling will affect winning reimbursement from public and private healthcare payers – not to mention product liability exposure.

The result is that medical device creators need to design their labels like they design their devices. Michael will discuss the importance of label design and share his four-step design process during this informative session.

This session will review the recent policy developments at FDA with regard to the use of patient preference and patient experience data in regulatory decision-making. FDA has made it a priority to incorporate the patient voice in the review of new medical devices. Further, FDA is encouraging medical device companies to include patient preferences in the total product lifecycle (TPLC) of new and existing devices. New guidance documents are now available, and FDA continues to hold frequent webinars, meetings, and workshops for the purpose of making clear their intentions and expectations for this new regulatory process. However, there are many aspects of this regulatory process that remain unclear. The implications for FDA’s intense focus on patient data for the development and commercialization of medical devices will be discuss. In addition, recent experiences and lessons learned will be shared within the context of this rapidly evolving regulatory landscape.

Takeaways:
1. Understanding of recent FDA policy and guidance with regard to the use of patient preference and patient experience data in regulatory decision-making.
2. Implications for the use of patient preference and patient experience data in the medical device TPLC.
3. Lessons learned for the implementation of patient preference and patient experience studies.
4. Recommendations for including patient preference and patient experience data in device development and regulatory review.

There is an influx of medical devices entering the global market, expected to reach $343 billion by 2021. The increased availability of healthcare and the ageing population contribute to this growth, along with the promise of better outcomes enabled by Internet-connected devices.

And we hear it all the time: devices “breaking through” because they’re on-demand, AI-driven, real-time, big data, etc. What does this all actually mean? How can we filter out the noise and avoid too much data we can’t use? How can medical devices be developed with a safe, continuous, and truly patient-first approach to connectivity? How can YOU contribute?

Hear from Nersi Nazari, CEO of VitalConnect – the country’s leading wearable biosensor – on how connected devices can be 10x more useful and made scalable within hospitals and at home.

Medical Device Manufacturing has many requirements, including regulatory constraints, standardized practices, identification and precision. In the future, we’d want even shorter runs of specialized devices, customized to patient needs.

The use of IoT and Edge Computing will allow sensory systems, strategically implemented in the manufacturing chain to develop a feedback system for all floor activities including Manufacturing, QA, Maintenance and other activities. The use of robotics is already standardizing, automating and optimizing medical device manufacture and assembly.

The use of IoT sensory systems, and the use of both edge computing, and over the longer term, Machine Learning and AI will allow for more precise control of processes, defect reduction, quality and cost optimization and other benefits.

The goal of Factory 4.0 is to implement sensors, automate and collect immense amounts of data on all activities performed on the floor, and the use of edge/cloud computing to get nearly instantaneous results, as well as the long term pattern recognition through AI/ML algorithms and techniques. We’ll discuss how adopting the above mentioned technologies can lead to high quality, highly customized, compliant medical devices.

Takeaway #1: The advantages of a data-driven manufacturing establishment
Takeaway #2: The benefits of Edge Computing in driving instantaneous insights
Takeaway #3: IoT, ML and AI can help with maintenance, upgrades and customization
Takeaway #4: Robotics, along with the other tools can be used to customize production for shorter batches of precise medical devices (edited)

Is printing a knee really any different than printing a drug? The regulatory strategies are exactly the same! Interested in 3-D printing applications in medicine, not just what we are doing today but what we could be doing in the future and how do we get there? For example, can we ‘print’ medical devices? can we ‘print’ permanent implants? can we ‘print’ combination products? can we ‘print’ drugs (i.e., new molecular entities)? can we ‘print’ living tissue? What are the technical and regulatory challenges these new technologies pose? Using case studies from a variety of clinical specialties, all of these and more will be discussed in this interactive webinar. Strategies for using regulation as a competitive advantage will also be discussed.

Key Takeaways:
• Understand what is currently being done in biomedical 3-D printing
• Appreciate the technical and regulatory challenges and how to address them
• Be aware of applications and technologies underdevelopment

Having been on both sides of the supplier selection process in large and small companies, Mark learned many pitfalls and rewards in selecting the right suppliers.

There are many factors besides cost that need to be determined when assessing a new medical device manufacturing partner.

In this session, you will learn methods for selecting and prioritizing potential contract manufacturers. The upfront effort you put into the process will determine your long term costs, not just the cost of the parts.

Healthcare is moving out of the hospital, meaning that medical devices need to be connected to the internet. Since many patients have smartphones in their pocket at all times, device manufacturers can easily use Bluetooth to send data from their device to a smartphone app, and then to a cloud application.

But hackers love to break stuff, and medical devices have been historically easy to hack. The newest Bluetooth protocol releases include support for encryption, so many device manufacturers feel their devices are safe if they’re using Bluetooth. Unfortunately, Bluetooth vulnerabilities are found regularly, meaning that a medical device’s software may be periodically vulnerable to attacks until patched.

At this exclusive 10x Workshop, you will get a private lesson from one of the world’s best marketers in healthcare. In two hours Mike Sperduti will present a consolidated version of the 7-Step Sales Program. This course teaches effective and straight-forward strategies for every step of the sales process. Students will develop a predictable and repeatable sales process that will enable them to close an abundance of new business and build long-lasting relationships.

This workshop will primarily be geared to accommodate our sponsor and exhibitor partners.

Data Science has been the buzzword for the past few years, but many companies are still struggling on how to effectively use it in their products. We will discuss a few examples on how companies are integrating data science outcomes into their products and help you formulate strategies on how to effectively bring analytic algorithms to support your business and bring added value to your customers. This session will help you understanding common challenges and pitfalls business experience integrating Data Science into their products.

Intellectual property rights and attendant issues may arise at many stages of medical device development. Both the internal and external landscape of IP rights are critical drivers in medical device, research, design, development and commercialization.

We will explore the nature and role of IP counsel in identifying IP rights, navigating third party IP rights and devising an IP portfolio that is aligned with the desired company outcomes. Further, we will discuss the ideal relationship and processes between IP counsel and R&D engineers and management that optimizes IP protection.

LEARNING OBJECTIVES:
• Takeaway #1: IP is not just obtaining patents for your device
• Takeaway #2: IP portfolios are built to enhance company value
• Takeaway #3: Management and engineering processes must include IP sensitivity
• Takeaway #4: IP should be part of the company culture

INCREDIBLE is the word I use would describe it. I’ve never been to a conference where I made connections like this one. Nothing comes close to it and I really appreciate how you go out of the way to help everyone connect.

It was the best conference I’ve attended, and I plan to be back next year. Maurizio Vecchione’s talk was inspiring, and several of the other presenters gave me perspectives on changes in medical devices I hadn’t considered. Thank you, Joe, for your attitude that keeps the conference fun, engaging, and constantly improving!

It just gets better and better. As soon as I got home, I realized I am never not going to go to 10x. From technology to trends, hard-won insights from panelists to challenges for the industry – this is a MUST ATTEND event.

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